Kornimate/medical-research-clean huggingface dataset:
treatment of anemia in diabetic subjects with ckd

Conditions: Anemia

Summary: the purpose of this study is to compare the proportion of subjects receiving either epoetin alfa (procritâ®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline by week 17.

this is a prospective, randomized, double blind, placebo controlled, multi-center study in diabetic subjects with the anemia of chronic kidney disease. subjects will be randomly assigned in a 1:1 ratio to receive either epoetin alfa (procrit®) or matching placebo for sixteen weeks. epoetin alfa (procrit®) is indicated for the treatment of anemia associated with chronic renal failure (pre-dialysis), non-myeloid malignancies receiving chemotherapy, in hiv-infected subjects receiving zidovudine therapy, and in anemic subjects undergoing elective non-cardiac, non-vascular surgery to reduce the need for allogenic blood transfusion during high-volume blood loss procedures. this study is being undertaken to assess, under well-controlled conditions, the effect of weekly epoetin alfa (procrit®) treatment on hemoglobin response in diabetic subjects with the anemia of chronic kidney disease. the study hypothesis is that weekly procrit treatment will be effective in achieving a hemoglobin response than placebo, where hemoglobin response is defined by at least a 1 gram/deciliter increase from baseline by week 17. the subjects are administered study drug (procrit® or matching placebo) once weekly by subcutaneous injection by a health care professional for 16 weeks. the initial dose of study drug is either procrit® 10,000 u (1.0 ml) or matching placebo. the maximum dose administered is 20,000 u (2.0 ml).

Eligibility criteria:
inclusion criteria: * subjects with a clinical diagnosis of diabetes mellitus * history of documented proteinuria or microalbuminuria * a glomerular filtration rate between 15 and 90 ml/minute/1.73m2 * subjects with hemoglobin greater than or equal to 9.0 /dl and less than or equal to 11.0 g/dl. exclusion criteria: * a current diagnosis of poorly controlled high blood pressure (hypertension) (systolic blood pressure \> 150 mm hg or diastolic blood pressure \> 100 mm hg) after adequate anti hypertensive therapy * subjects with severe neuropathy or peripheral vascular disease with gait instability * subjects scheduled to receive dialysis during the course of the study * subjects with a transferrin saturation \< 20% or ferritin level \< 50 ng/dl * subjects with active malignancy, defined as a malignancy requiring current therapy (surgery, chemotherapy, or radiotherapy) or a history of treatment for malignancy in the last 5 years.

Keywords: anemia chronic renal failure pre-dialysis diabetic
contribution of supar for patients in a situation of uncertainty downstream of emergencies

Conditions: Emergencies; Disease; In-hospital Observation

Summary: in this study, the investigators will investigate the relationship between the blood level of supar at admission to the emergency department of the clermont-ferrand university hospital, and the outcome of patients after their hospitalization in a short stay unit.

supar (soluble urokinase plasminogen activator receptor) is a non-specific prognostic blood biomarker related to inflammation. an elevated supar value reflects significant chronic inflammation and predicts a risk of negative outcome and even short-term mortality (intra-hospital, 30 days, 90 days). conversely, a low supar value is a strong indicator of good prognosis and low risk of readmission. it is therefore of interest to know a patient's supar blood level to enable the clinician to decide whether the patient should be admitted or discharged. supar has been shown to be the best prognostic marker associated with the presence and progression of disease and risk of mortality. the use of supar in clinical routine adds significant complementary information to the standard early warning score assessment and to the classical parameters such as crp, pct, lactate, alt, bilirubin, and cbc in the pre-admission of acute patients. patients admitted to the emergency department will receive their usual management. we will test the added value of the supar assay in the prognosis of patients' outcome at discharge.

Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years old * admitted to the emergency department of the clermont-ferrand university hospital for a medical reason, * classified as french ii or iii by the nurse organizer of the reception management * necessity of clinical observation in the short term hospitalization unit for final orientation decision * requires a blood test upon arrival in the emergency department * able to give informed non-opposition to participate in the research. * affiliation to a social security system exclusion criteria: * patient under guardianship or curatorship * pregnant and breast feeding woman * patient admitted for psychiatric pathology * patient with a limitation of therapeutics * refusal to participate * patient hospitalized because of a particular social context

Keywords: supar patient triage emergency
japanese study evaluating the effects of telithromycin in children with acute otitis media

Conditions: Otitis Media

Summary: the primary objective is to assess the safety of telithromycin (hmr3647) 20 mg/kg qd for 5 days in children with acute otitis media (aom). secondary objectives are to assess efficacy, pharmacokinetics and acceptability of telithromycin 20 mg/kg qd for 5 days in children with aom.


Eligibility criteria:
inclusion criteria: * subjects who are weighing 40 kg or less. if female, premenarchal status is required. * subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: acute otitis media aom children child
measuring cardiovascular stress in patients on hemodialysis

Conditions: Hemodialysis; Hypotension; Circulatory Stress; Photo-plethysmography

Summary: to determine if proprietary software that uses pulse-wave analysis to interpret the output of a conventional pulse-oximeter, can predict the onset of circulatory stress, before changes in blood pressure and pulse occur, in patients undergoing outpatient hemodialysis.


Eligibility criteria:
inclusion criteria: * patients having regular outpatient dialysis treatments * patients who are willing and able to provide informed consent exclusion criteria: * patients who do not wish to participate * patients with contraindications to attachment of monitoring devices * patients with skin rash or hypersensitivity to the adhesive sensors

Keywords: hemodialysis hypotension circulatory stress photo-plethysmography
efficacy assessment of scenar device on common spinal pain syndrome

Conditions: Pain Syndrome

Summary: randomized, singled blinded, controlled trial of the efficacy of a scenar session in patients with vertebral pain. scenar is an electrotherapy device.


Eligibility criteria:
inclusion criteria: * male or female over 18 and under 80 years of age * suffering of common spinal pain: cervical pain including cervico-brachial neuralgia, lumbar pain including lumbo-radiculalgia * having attended a "pain consultation" or referred to a pain consultant during hospitalization * having signed the consent form * can be contacted directly by phone if patient is not hospitalized * be affiliated to a national insurance scheme or benefiting from such a program non-inclusion criteria: * pregnant or breast-feeding women * patients with a pacemaker * patients whose skin condition makes the use of scenar impossible (wounds, recent scars, skin infections) * patient whose spinal pain is known to be related to inflammatory pathology (spondylarthropathy, rheumatoid arthritis, chondrocalcinosis), trauma (fractures and dislocations), tumor (metastases, myeloma localization), spondylodiscitis infectious, neurological (intrarachidian tumor or posterior fossa) or radiculalgia with deficient signs * patients who have already had a scenar session * patients who have already participated in this study

Keywords: spinal pain
acupuncture and post-operative ileus

Conditions: Ileus

Summary: postoperative ileus, the transient cessation of normal bowel function, is a universal aspect of colon surgery. its occurrence may lead to increased patient discomfort and additional time and cost to hospital stay. evidence from previous studies indicate that acupuncture may be beneficial in decreasing time to recovery of bowel function and decrease the body's inflammatory response. however, this has not been studied in a randomized, prospective fashion in colon surgery. the goal of this study is to determine if acupuncture may be utilized as a therapeutic modality to decrease time to return of bowel function and discharge from the hospital.

the pathogenesis of post-operative ileus is not completely known. it is thought that post-operative ileus involves trauma to the bowel. this traumatizing of the intestine and peritoneal surfaces results in production and release of inflammatory mediators. these in turn, lead to inactivation of inhibitory neural reflexes. there is also an additive effect of opioids used for post-operative pain, aggravating and adding to the duration of post-operative ileus. acupuncture has shown promise in both human and animal model studies to reduce post-operative nausea and vomiting and post-operative ileus. it is the investigator's hypothesis that acupuncture will minimize or reduce both post-operative ileus and nausea following elective colon surgery and will lead to a decrease in inflammatory markers that are known to be elevated following abdominal surgery. the study goals are to determine if acupuncture: * leads to earlier return of bowel function * leads to earlier time to discharge following colon surgery * leads to earlier return of colonic motility * leads to decreased postoperative nausea and vomiting * leads to a decrease in inflammation

Eligibility criteria:
inclusion criteria: * male or female * age 18-89 * colorectal pathology requiring standard elective open or laparoscopic colectomy exclusion criteria: * pregnancy * pacemaker or implantable electronic devices * bowel obstruction * intra-abdominal abscess or sepsis * colorectal tumors invading other organs or surrounding tissues * diverticulitis complicated by fistula * known immunodeficiency disorders * tumors requiring an anastomosis below 7cm above the anal verge as measured by rigid proctosigmoidoscope exam at surgery * chronic pain medications * surgeries requiring temporary or permanent ostomies * emergent operations * receiving preoperative radiation/chemotherapy * major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupunctural treatment areas

Keywords: acupuncture colon surgery post operative ileus post ileus ileus colectomy colorectal pathology
the effects of overfeeding on obesity-prone (op) and obesity-resistant (or) women

Conditions: Obesity; Thinness; Weight Gain

Summary: this is a longitudinal cohort study of how the responses to a 3 day period of controlled overfeeding relate to subsequent weight gain. we hypothesize that thin individuals are resistant to weight gain because they respond to periods of overfeeding by increasing fat oxidation, reducing food intake, and increasing physical activity relative to those who gain weight over time.


Eligibility criteria:
* half of the subjects will be women, half will be men, * age 25-35, * a range of bmi's from 19-27, for the 'thin subjects' there should be no 1st degree relatives with a bmi\>30. * subjects should not engage in planned physical activity more than 3 hrs per week. * for the obesity prone group there should be at least 1 1st degree relative with a bmi\>30.

Keywords: obesity thinness weight gain physical activity diet fat oxidation hunger feeding behavior overfeeding
double-blind comparison between mitiglinide and nateglinide in type 2 diabetic patients

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety of mitiglinide compared to nateglinide for the treatment of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy exclusion criteria: * type 1 diabetes patients * patients who require treatment with insulin * patients with severe diabetic complications (neuropathy, retinopathy or nephropathy) * patients with severe ketosis, diabetic coma or precoma * patients complicated with severe hepatic diseases * patients complicated with severe renal diseases * patients complicated with severe hypertension * patients complicated with severe cardiac disease * pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period

Keywords: diabetes rapid and short acting insulin secretagogue α-glucosidase inhibitor hba1c insulin
music intervention in exercise and sport on problematic smartphone use, psychopathological symptoms among college students

Conditions: Problematic Smartphone Use

Summary: this study is to examine the effect of music intervention in exercise and sport on problematic smartphone use, psychopathological symptoms, self-esteem, and impulsivity traits in smartphone users among chinese college students. the aim is to compare the effects of the combination of exercise and sport with fast-tempo music, slow-tempo music, and no music.


Eligibility criteria:
inclusion criteria: * university students aged between 18 and 25 years old (male or female) * no cognitive impairment and able to complete the questionnaire clearly exclusion criteria: * students with recent injuries such as broken bones, congenital diseases such as heart disease, or other status conditions that prevent them from playing moderate-to-high-intensity sports * excluded students with mental diseases, physical disabilities, or those who were unable or unwilling to participate in the trial
effect of hearing aid versus cochlear implant on hearing and speech recognition in children

Conditions: Speech Disorders

Summary: this study examines the comparative effects of hearing aids and cochlear implants on hearing and speech recognition in children with hearing loss. this research adopts a quantitative approach to compare the outcomes of children using hearing aids versus cochlear implants. data will be collected through audiological evaluations, including aided audiometry and speech recognition tests conducted in an audiology clinic. descriptive and inferential statistical analyses will be used to determine differences between the groups.

the study aims to provide evidence-based guidance for audiologists, educators, and caregivers regarding optimal device selection and management. by identifying the strengths and limitations of each intervention, the findings will contribute to improved rehabilitation strategies, ultimately enhancing auditory and speech outcomes in children with hearing loss. this research holds significance for advancing clinical practices in pediatric audiology.

Eligibility criteria:
inclusion criteria: * children with 6-18 years of age * bilateral hearing aid users with moderate to severe degree sensorineural hearing loss. * unilateral cochlear implant users with severe to profound degree sensorineural hearing loss and no amplification to other ear. * consistent use of hearing aid or cochlear implant for more than 1 year. * known or presumed early onset of hearing loss before 3 years of age * urdu as primary language of education * enrolled in rehabilitation program (school or pre-school for hearing impaired children) focused on oral communication. exclusion criteria: * children below 6 years or above 18 years * children with less than 1 year of consistent use of hearing aids or cochlear implant * children with cognitive, neurological or developmental disorders."
a randomized control trial of a digital health tool

Conditions: Suicide and Self-harm

Summary: this randomized trial evaluated whether sending population-based invitation messages through the electronic health record to visit lock to live (l2l), a web-based decision aid that incorporates patients' values into recommendations for safe storage of firearms and medications, impacted readiness to change firearm and medication storage behaviors.

lock to live (l2l) is a web-based decision aid that incorporates patients' values into recommendations for safe storage of firearms and medications. this randomized trial evaluated whether sending population-based invitation messages to visit l2l through the electronic health record (ehr) to patients treated in primary care and mental health specialty settings with elevated suicide risk, identified using a prediction model, impacted readiness to change firearm and medication storage behaviors. patients were identified using previously validated suicide risk prediction models developed within the mental health research network (mhrn). these models are highly predictive of suicide attempt and death by suicide for both a 30-day and 90-day period. patients in the 75-99.5th risk percentiles were randomized. half were randomized to receive l2l+survey (intervention) and half received survey only (control). and control groups. over 21,000 unique patients were enrolled over a 6-month period. survey respondents were assigned to one of five groups based on readiness for change: pre-contemplative (do not believe in safe storage), contemplative (believe in safe storage but not doing it), thinking (considering changing storage), preparation (planning to change storage), or action (safely storing). data will be analyzed using chi-square, logistic and multinomial logit models to test for differences between intervention and control groups.

Eligibility criteria:
inclusion criteria: * aged 18 years or older (\>18 yrs.) * suicide risk based on validated risk algorithm (patients falling within the 75th- 99th risk percentile based on the suicide risk algorithm) * patients with a recent visit within mental health department or within primary care department w. mental health diagnosis (recent defined as within the prior month from the date of the algorithm run date) * english noted as primary language, or patient flag for interpreter needed is not set * patient is not deceased * patient is registered on kp.org to receive online message exclusion criteria: * a recorded diagnosis of: dementia/ or other cognitive impairment (including developmental delay), psychosis, schizophrenia, autism spectrum disorder * non-english speaker * receiving home-based palliative care, or hospice care * in a skilled nursing facility * on the research exclusion list - do not contact * patient has flag for health proxy
phase 2 study of ttx-030 and chemotherapy with or without budigalimab for 1l mpdac patients

Conditions: Pancreatic Cancer

Summary: this is a phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of ttx-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic pdac who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as soc.


Eligibility criteria:
abbreviated inclusion criteria: 1. age 18 years or older, is willing and able to provide informed consent 2. histologically or cytologically confirmed diagnosis of metastatic pdac. 3. no prior systemic treatment for metastatic disease. 4. evidence of measurable disease per recist 1.1. 5. appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy. 6. eastern cooperative oncology group (ecog) performance status score of 0 or 1. abbreviated exclusion criteria: 1. history of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody 2. use of investigational agent within 14 days prior to the first dose of study drug 3. history of autoimmune disease 4. subject has received live vaccine within 28 days prior to the first dose of study drug 5. has uncontrolled intercurrent illness

Keywords: cancer pancreatic adenocarcinoma combination therapy cd39 adenosine pathway immunotherapy immuno-oncology pancreatic ductal adenocarcinoma pd-1 checkpoint inhibitor budigalimab ttx-030 metastatic
acupuncture for oligomenorrhea due to polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome; Oligomenorrhea

Summary: this study is an international multicenter, pilot randomized, assessor-blind, controlled trial, which is aimed to preliminarily investigate the efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome (pcos).

a total of 60 subjects will be recruited and randomly allocated into experimental or control group with 30 subjects respectively. the subjects in experimental group will receive a standardized acupuncture treatment plus usual care, whereas the ones in control group will be managed only with usual care.

Eligibility criteria:
inclusion criteria: * oligomenorrhea (menstrual cycle\> 35 days or less than 8 cycles per year) plus at least one of the following two criteria; hyperandrogenism (clinical, biochemical, or both) and/or polycystic ovarian morphologic features \[12 or more antral follicles (2 to 9 mm in diameter) in either ovary, an ovarian volume that is greater than 10 ml in either ovary, or both\] * 20-40 years of age * voluntary agreement to participate in this trial exclusion criteria: * pregnancy, labor or breastfeeding within the past 3 months * intake of oral contraceptive or ovulation inducing agent within the past 3 months * severe oligomenorrhea with menstrual period over 3 months * menstruation during more than 8 days * premature ovarian failure * resistant thyroid disease, cushing's disease, congenital adrenal hyperplasia, or hyperprolactinemia * ovarian tumor or adrenal tumor that cause hyperandrogenemia * hemorrhagic disease * severe cardiac, pulmonary, hepatic, or renal diseases, central nervous system disorders, or intake of psychoactive drug * acupuncture treatment within the past one month * participation in other clinical trial within the past 3 months * other conditions judged to be inappropriate for the clinical study by the investigators

Keywords: polycystic ovary syndrome oligomenorrhea acupuncture